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EMA Addresses Ben Venue Quality Issues

After reviewing the “shortcomings in quality assurance” that were recently identified at Ben Venue Laboratories’s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta, Liminity and Vistide. EMA’s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011, after a joint GMP inspection by FDA and the UK and French medicines regulatory agencies highlighted several problems in the company’s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing.

In two recent updates on the situation, EMA initiated a precautionary recall of 14 batches of Ecalta, an antifungal medicine, one batch of the diagnostic medicine Luminity, which has already been quarantined, and one batch of Vistide, which is used to treat cytomegalovirus infections of the retina. Originally, the EMA had thought that there would be no risk of lack of sterility of Vistide because the medicine is sterilised at the end of the manufacturing process. However, the EMA now believes that there is a possible contamination risk of particles.

The agency has also advised healthcare professionals to visually inspect the vials of anticancer medicines Ceplene and Torisel for the presence of particles before administration. Both medicines are considered essential for certain cancer patients and can only be acquired from Ben Venue.

The recommendations mark the second time that EMA has provided guidance for dealing with the shortcomings in quality assurance at Ben Venue. In November, the agency released an earlier set of recommendations stating that, as a precautionary measure, only medicines that are “absolutely essential” to patients and unavailable from another source can be used from the Ben Venue site.

In the earlier statement, EMA explained that the supply of oncology medicines Busilvex, Velcade, and Vidaza was nonessential as alternatives are available in the EU market. As a precautionary measure, a recall of all three medicines was also undertaken.

The review of medicines manufactured by Ben Venue is ongoing, and EMA says that it will make further updates as appropriate. For each product, however, the agency will consider whether supply is essential to meet clinical needs and whether alternative options are available. Current EU stock levels will also be taken into account.